IRB
burden studied in cost analysis

By
MICHELLE L. BRANDT

Keith Humphreys, PhD, knew at the start of his multicenter trial on
substance abuse treatment that dealing with institutional review
boards — the groups that oversee research involving human
subjects at universities and hospitals — would be a
challenge. But he didn’t realize how much of a challenge it
would be. His experience was so eye-opening that he decided to
examine the issue more carefully and conduct an economic analysis
of IRB activities.

"The economic study came out of
frustration over what we went through," said Humphreys, associate
professor of psychiatry and behavioral sciences at the School of
Medicine and the Veterans Affairs Palo Alto Health Care System. "We
tried to make lemonade out of lemons."

Humphreys’ economic analysis found that nearly 18 months
and 17 percent of the total research budget for his multicenter
observational study were spent on IRB activities. He also found
that the IRB procedures — despite being costly and
time-consuming — had no discernible impact on human subject
protection.

"The essential procedures of the
study never changed substantially, despite exchanges of more than
15,000 pages of material among the nine IRB sites," Humphreys wrote
in a letter published last month in the Annals of Internal
Medicine. He referred to the IRB activities as "$50,000 of
paper shuffling" and said he hopes this economic analysis will lead
to further examination of IRB procedures.

Federal Food and Drug Administration regulations give IRBs the
authority to approve or require modifications in human research. In
a multicenter trial, the IRB at the coordinating center (the "home
IRB") must approve the research protocol in order for the study to
continue. IRBs at each participating site have discretion in how
intensively they re-review an approved protocol, and IRBs may be
less compelled to review the protocols of observational
(non-experimental) studies, which pose minimal risk to
participants.

The
home IRB approved the research protocol for Humphrey’s
observational study on treatment for heroin addiction, yet the IRBs
at participating sites chose to conduct independent, full-board
reviews — sometimes by multiple local committees. The IRBs
also expected final say on the protocol, meaning they conducted new
reviews each time there was a change in study documents.

Humphreys reported that the IRBs requested numerous revisions
to the formatting and wording of consent procedures and patient
survey forms and had difficulty agreeing with each other on the
details of the protocol. Disagreement involved changes as trivial
as saying "study description" rather than "description of study,"
he said. The IRBs would not directly communicate with one another,
and Humphreys and his team at the coordinating center did numerous
back-and-forths until a consensus was reached. In the end, when
each IRB signed off on the study protocol, little of substance had
changed.

"We spent thousands of dollars doing
things like changing the font from Helvetica to Times New Roman and
making sure the border of the forms were the right color," said
Humphreys. "I couldn’t believe how much time and money the
process was taking."

The
researchers’ economic analysis found that these IRB
activities, including initial reviews, continuing reviews and
amendments reports, cost more than $56,000 or just less than 17
percent of the total research grant budget for the first 18 months
of the study. Most of these costs ($29,824) reflected the
IRBs’ expenditures for supplemental actions (activities that
occurred after the home IRB had already approved the protocol). The
researchers also found that the protocol did not significantly
change after all the reviews.

"This was essentially a public-private sector collaboration to
lose money," said Humphreys.

While agreeing that oversight of human research is crucial,
Humphreys said it is important for people to realize that there are
problems with the procedures. "If costs such as those identified in
this project continue to grow without consideration of the benefits
of facilitating scientific projects, we worry that future research
may be unjustly affected," he wrote in the letter.

Humphreys’ hope is that researchers and policymakers
engage in a dialogue on IRB procedures and begin to weigh the cost
and benefits of multi-center review for minimal-risk studies, such
as his initial observational study. Given the budgetary pressures
that hospitals and research facilities now face, he said this is a
particularly timely issue.

Humphreys’ collaborators on the economic study include
Jodie Trafton, PhD, health science specialist and voluntary
clinical instructor of psychiatry at the VA Palo Alto Health Care
System, and Todd H. Wagner, PhD, consulting assistant professor of
medicine and health economist, also with the VA. The study was
funded by the Department of Veterans Affairs Health Services
Research and Development Service.